Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic Systems Corp., a nebus company, Mundelein, IL 60060; Model 580-T2ASM2. (a Digital EEG/Sleep Recorder Electroencephalograph that includes a built-in pulse oximeter, body position sensor, snore monitor, chest, abdominal and air flow transducers and electrode array for EEG, EMG and EOG)
FDA Recall Z-0761-2007 · Posted 2007-04-20
Recalling FirmBio-Logic Systems Corp
Recall StatusTerminated
Product CodeGWQ
Date Initiated2007-02-26
Date Terminated2008-08-26
Product Quantity130 battery packs (112 domestic USA, 18 foreign)
Reason for Recall
Battery and Battery Compartment; incorrect placement in the Netlink Traveler unit which caused a short in the wiring of the battery pack and overheating.
Firm Action
On 2/26/07, Bio-logic Systems shipped replacement batteries, marked with part number 520-LIBAT4-3 and a label reading 'THIS SIDE OUT', and a new battery compartment cover with a label inside the cover to clarify the correct installation of the battery to each of the affected customers. The accounts were requested to remove and replace the old batteries, part 520-LIBTA4-2, and compartment covers, and return the old batteries and covers to Bio-logic Systems in the enclosed pre-paid shipping container, along with the completed accounting form.
Root Cause
Other
Distribution Pattern
Worldwide, USA , Canada, China, Hong Kong, India and Israel.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.